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Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Patients benefit from earlier access to technologies that could improve or save lives, as the MHRA approved 17 per cent more clinical investigations in 2025 compared with 2024, and launches measures to support innovation and growth.
How to conform with the legal requirements for placing medical devices on the market.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Reforms to ensure that medical device regulation is fit for purpose for software products, including artificial intelligence (AI).
Information about the MHRA's duties and how you can report a non-compliant medical device.
10 guiding principles that can inform the development of good machine learning practice (GMLP).
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